Continuous Glucose Monitoring and Cerebral Oxygenation in Preterm Infants

NCT04347590 | Unknown DMC FDA Device

• 1 other identifier: AOP1813
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Neonatal hypoglicaemia is associated with impaired neurodevelopment outcomes in preterm infants. Thus, hypoglicemic events should be diagnosed and treated promptly. Unfortunately, hypo- and hyperglicaemia management is still controversial. The investigators aim to assess if a continuous glucose monitor (CGM) impacts on both short-term and long-term neurodevelopment. Primary outcome is the effect of CGM coupled with a control algorithm for glucose infusion on the number of hemodynamic significant events (defined as hypoglycemic events associated with DOT-detectable reduction of brain oxygenation). It will be enrolled newborns ≤32 weeks gestational age and/or of birthweight ≤1500 g, they will be randomized in two study arms, both of them will wear Medtronic CGM during the first 5 days of life: 1) Blinded group (B): the device monitor will be switched off, glucose infusion rate will be modified according to the daily capillary glucose tests. 2) Unblinded group (UB): the device monitor will be visibile, alarms for hypos/hyper will be active and glucose infusion rate will be modulated according to CGM and PID control algorithm. Enrolled newborns will also be monitored with near-infrared diffuse optical tomography (DOT) during the first 5 days from enrollment. Follow-up will be performed at 12, 18, 24 months and 5 years by neurodevleopmental scale (Bailey III until 24 months; Wechsler Preschool and Primary Scale of Intelligence (WPPSI) at 5 years). The estimated numerosity is 60 patients (30 for each arm).

Conditions

Infant Development; Hypoglycemia Neonatal; Neurodevelopmental Abnormality

Keywords

continuous glucose monitoring (cgm); neonatal hypoglycemia; preterm infants; diffuse optical tomography (dot)

Outcome Measures

Primary Outcomes (1)

• CGMS and brain hemodynamic (posterior areas)

  Number of hypoglycemic events henomdynamically significant. Hypoglycemic events are defined as any value \<72mg/dL (mild hypo) or \<47mg/dL (severe hypo). They are classified as "significant" in the presence of a reduction from baseline HbT \>=15% (posterior areas)

  5 days

Secondary Outcomes (8)

• CGMS and brain hemodynamic (overall)

  5 days

• Long-term neurodevelopment

  24 months

• Long-term neurodevelopment 2

  12 months

• Long-term neurodevelopment 3

  18 months

• Long-term neurodevelopment 4

  36 months

Study Arms (2)

Unblinded CGM

EXPERIMENTAL

CGM data will be "unblinded", with Hypo/hyperglycemia alarms on. Data will be recorded from CGM every three hours and intervention to adequate glucose intake will be performed to keep glycemia in normal range (72-144mg/dl) if necessary.

Device: Unblinded - CGM (Medtronic Guardian)

Blinded CGM

OTHER

Hypo/hyper alarms are off. CGM data will be blinded. Glucose intake will be adequate according to at least 2 capillary glycemic tests per day.

Device: Blinded - CGM (Medtronic Guardian)

Interventions

Unblinded - CGM (Medtronic Guardian) DEVICE

Data from device will be readable and alarms on

Unblinded CGM

Blinded - CGM (Medtronic Guardian) DEVICE

Data from device will be blinded and alarms off

Blinded CGM

Eligibility Criteria

• Age: 2 Hours - 2 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \<= 32 weeks gestation
• birthweight \<1500 g

You may not qualify if:

• birthweight \<500g
• congenital pathologies
• lack of parental consent
• perinatal maternal infections
• albinism

Sponsors & Collaborators

• University Hospital Padova: lead
• University of Padova: collaborator

Study Sites (1)

Neonatal Intensive Care Unit - University Hospital of Padua

Padua, 35128, Italy

RECRUITING

Related Publications (24)

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Study Officials

• Alfonso Galderisi, MD

  University Hospital of Padua

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alfonso Galderisi, MD

CONTACT

+390498213545; alfonsogalderisi@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: April 12, 2020
• First Posted: April 15, 2020
• Study Start: April 24, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2025
• Last Updated: November 25, 2020

Record last verified: 2020-11

Locations

IT (1)